Quality Specialist

Responsibilities:

Develop specifications for raw materials, components, intermediate products,and Finished Drug Product.

Plan, execute, and oversee inspection and testing of product to confirm qualityand conformance to

specifications and test methods for raw materials, components,intermediate products, and

Finished Product.

Monitors applicable pharmacopeias to assure timely implementation of methodchanges as applicable.

Provide QA support during investigations efforts on quality events, includinginvestigation technical writing.

Review and approve applicable quality events ensuring appropriate CAPAs areidentified and implemented.

Identify and implement quality continuous improvement processes (bothinternally and externally) which

increases efficiency and maintains high qualitystandards.

Review and approve master and executed batch records.

Provide quality assurance GMP oversight to manufacturing, QC testing and batchrelease.

Provides visibility to cross-functional team to qualify, transfer and implementchanges.

Review and approve Validation, Qualification and Technology Transfer Protocoland Reports for Equipment,

Process, Facility, and IT systems.

Ensure systems are in compliance with current SOPs.

Interact with multiple business functional areas (e.g., Quality Control,

Operations, Facilities, etc.), ensuring GMP quality compliance and best practices aremet.

Report quality issues to ensure resolution in accordance with company guidelinesand external regulatory

requirements

May perform additional duties as required.

Requirements

Required:

Education and Experience :

Bachelor s degree in Science preferred.

5+ years of quality and/or manufacturing experience in a pharmaceutical orbiotech environment.

Expertise in U.S. and international GMPs. Must understand standards of practicefor GMP training.

Previous experience in quality assurance or a similar field.

Working knowledge of tools, methods, and concepts of quality assurance.

Solid knowledge of relevant regulatory standards.

Good communication skills, both verbal and written.

Excellent data collection and analysis skills.

Strong attention to detail.

Proficiency with Microsoft Suite (Word, PowerPoint, and Excel)

Benefits

Permanent Position

Benefits Package

Responsibilities: Develop specifications for raw materials, components, intermediate products, and Finished Drug Product. Plan, execute, and oversee inspection and testing of product to confirm quality and conformance to specifications and test methods for raw materials, components, intermediate products, and Finished Product. Monitors applicable pharmacopeias to assure timely implementation of method changes as applicable. Provide QA support during investigations efforts on quality events, including investigation technical writing. Review and approve applicable quality events ensuring appropriate CAPAs are identified and implemented. Identify and implement quality continuous improvement processes (both internally and externally) which increases efficiency and maintains high quality standards. Review and approve master and executed batch records. Provide quality assurance GMP oversight to manufacturing, QC testing and batch release. Provides visibility to cross-functional team to qualify, transfer and implement changes. Review and approve Validation, Qualification and Technology Transfer Protocol and Reports for Equipment, Process, Facility, and IT systems. Ensure systems are in compliance with current SOPs. Interact with multiple business functional areas (e.g., Quality Control, Operations, Facilities, etc.), ensuring GMP quality compliance and best practices are met. Report quality issues to ensure resolution in accordance with company guidelines and external regulatory requirements May perform additional duties as required. Required: Education and Experience : Bachelor s degree in Science preferred. 5+ years of quality and/or manufacturing experience in a pharmaceutical or biotech environment. Expertise in U.S. and international GMPs. Must understand standards of practice for GMP training. Previous experience in quality assurance or a similar field. Working knowledge of tools, methods, and concepts of quality assurance. Solid knowledge of relevant regulatory standards. Good communication skills, both verbal and written. Excellent data collection and analysis skills. Strong attention to detail. Proficiency with Microsoft Suite (Word, PowerPoint, and Excel)